Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000179730
Ethics application status
Approved
Date submitted
23/12/2021
Date registered
2/02/2022
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promotion of social prescribing from within a general practice (a pilot study)
Scientific title
Appropriateness and feasibility of promotion of social prescribing from within a general practice (a pilot study)
Secondary ID [1] 306108 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social connectedness 324780 0
Health literacy 324781 0
Condition category
Condition code
Public Health 322232 322232 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Summary:
The project will deliver a practice improvement module to GPs to highlight the benefits of social prescribing (SP). Existing community networks ('hubs') in the Huon are used sporadically by GPs. The practice improvement module will provide a streamlined method of referring patients to hubs.

The project will measure the feasibility and appropriateness of this model of referral by surveying GPs at the onset of the pilot and after 6 months. The number of referrals provided and number of "completed" social prescribing interactions will be compared.
Patients' self-rated social connectedness and health literacy will be measured at the point of referral and after 6 months.
Community hub leaders' receptiveness of the referral pathway will be assessed by survey at the end of the pilot study period.

Detail:
The project is a pilot study to evaluate the feasibility and appropriateness of a GP-led SP referral model. Recent investigations by others (Judi Walker et al., unpublished) suggests that SP is loosely understood but nevertheless viewed positively and currently employed on an ad hoc basis by GPs. Phases of the study include:
1. In a SP Practice Improvement Education Module, the benefits of SP will be presented to GPs at the Huon Medical Group (HMG). GPs will be encouraged to continue referring patients at risk of, or experiencing, medical or social problems (including isolation, low health literacy, recent hospitalisation) for community-based activities. Current organisations that are imbedded in their local community will be presented as a ‘community hub’ and act as the primary contact for SP activities. One or more organisation from each geographical location (i.e. Huonville, Cygnet, Geeveston) will be designated as a local community hub.
The practice improvement module will be delivered via a single face-to-face educational session by one of the research team. Follow-up email communication addressed to all attendees will be used to address questions raised during the session. Ongoing reminders and any further information associated with the project will be delivered via email, the internal electronic communication system within the practice or verbally, as best suits the circumstance.
2. GPs working at HMG in Huonville, Cygnet, Geeveston will be invited to participate in: a. a baseline survey assess their awareness of existing local services, their attitude to SP, knowledge of SP and existing referral mechanisms, and b. a follow-up survey (at 6 months) to assess the feasibility and appropriateness of the highlighted referral pathway and its perceived benefits and challenges.
3. During routine practice GPs, practice nurses, social workers and other HMG staff will identify patients who may be suitable for referral to a non-medical, community-based social activity. The decision to recommend and agree upon such activities will remain part of the healthcare worker-patient interaction. Any patients who accept a recommendation to consider these activities will then be invited to participate in this research project. Patients can accept a referral for community based social activities without participating in the research. Patients will be prospectively recruited. Following the initial discussion about SP, patients will be offered a research study pack. The study pack will contain a study information sheet, consent form, baseline survey, self-addressed envelope and a referral form to their local community hub.
4. The patient will be permitted to take the information home, have time to read it, ask questions and complete paperwork. Contact details for questions and to request assistance in completing any documentation will be included in the patient information sheets and questionnaire forms. The research team will respond and provide assistance as required.
5. Patients will then be invited to return the completed consent form permitting baseline and follow-up survey participation. Completion of the baseline survey will be requested. A self-addressed envelope will be provided (addressed to the researchers c/- the University of Tasmania). Consenting patients will continue to be accepted throughout the duration of the 6-month study.
6. The community hub staff will continue to provide their existing services, specifically, using the same methods of meeting with individuals and connecting them with community activities. There will be no alterations to their usual practice model required as part of this project. The type of community activity will be decided by the patient and hub. Community hubs will be asked to retain the GP-issued referral forms of the referred patients to assist in follow-up at the completion of the study period. Consent will be obtained from the community hub representative to participate in a survey at the conclusion of the study.
7. One of the research team will ensure there are enough study packs available in each consultation room. A count of remaining packs will be undertaken every one or two weeks, depending on level of patient visitation and access to rooms. Ongoing reminders of the program will occur weekly or more often as required. Regular contact with each hub will be maintained to ensure referral forms are being collected and filed appropriately. Patient survey and consent forms will be collected from the University of Tasmania as they are returned.
8. Examples of activities delivered directly from the community hubs include signposting to other social services (government services, not-for-profit services), transportation, skills training (food preparation, wood/metalwork), and delivery of physical/social activities, Community hubs have links within their local area that facilitate the provision of recreational activities (boardgames, chat/advocacy groups, music appreciation, book clubs), craft groups (knitting crocheting, woodwork, boat building), exercise programs (aqua-aerobics, walking, yoga), educational courses (University of the Third Age, history creative writing), and social outings.
Intervention code [1] 322525 0
Lifestyle
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330006 0
General practitioners' perception of the appropriateness of a social prescribing pilot project:
Data collected from GPs will reflect their perception of current SP pathways and practices and at the end of the study period, their reception of the pilot intervention. Based on the work of Weiner et al., appropriateness of the intervention will be measured using the Intervention Appropriateness Measure (IAM). Additional questions will allow for free-text comments regarding the GP’s perception or thoughts about the intervention or SP in general.
Timepoint [1] 330006 0
0 months (baseline)
6 months (follow up)
Primary outcome [2] 330261 0
General practitioners' perception of the feasibility of social prescribing pilot project:
Data collected from GPs will reflect their perception of current SP pathways and practices and at the end of the study period, their reception of the pilot intervention. Based on the work of Weiner et al., feasibility of the intervention will be measured using the Feasibility of Intervention Measure (FIM) respectively.
Timepoint [2] 330261 0
0 months (baseline)
6 months (follow up)
Secondary outcome [1] 405503 0
Patient social connectedness:
Patient participants will have their social connectedness measured by the 6-item abbreviated version of the Lubben Social Network Scale (LSNS-6) as developed by Lubben et al. For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.
Timepoint [1] 405503 0
0 months (baseline)
6 months (follow up)
Secondary outcome [2] 405504 0
Patient health literacy:
Patient health literacy will be measured using selected scales from the Health Literacy Questionnaire (HLQ) as per Osborne et al.. Scales 1, 4, 6 and 7 will be included to measure health literacy,
Timepoint [2] 405504 0
0 months (baseline)
6 months (follow up)
Secondary outcome [3] 405798 0
Hub acceptance of the intervention
Timepoint [3] 405798 0
acceptance of the practice improvement model by community hub leaders will be measured using a questionnaire based on that developed by Weiner et al.

Eligibility
Key inclusion criteria
Description and number
The HMG employs 16 GPs of differing experience levels across three locations. In the course of their usual practice, it is likely that most GPs already refer patients for social activities. The project is intended to assess GP’s perceptions of the resultant practice improvement model. Approximately 30% of elderly patients in the HMG database have a status indicating they live alone. The proportion in the wider community may be lower due to younger people more commonly living with family, continual changing relationship statuses and living arrangements of individuals. The definition of living alone includes free-text entries of separated, widowed and single in patient medical records. There are approximately 5000 people aged over 18 years who regularly receive care from the HMG. Not all patients at risk of isolation who are offered a social prescription referral will accept the referral or wish to engage with the community hub. It is estimated that 100 people in 6 months will be successfully identified by GPs, accept a referral to a community hub and complete a baseline and follow-up assessment for inclusion in the SP pilot project. All community hub coordinators will be invited to participate. It is anticipated the number of participants will be no more than four, corresponding to the four hubs (Huon Valley Council (specifically the Huon Hub), Cygnet Community Hub, oura oura House and Geeveston Community House). Given the small number of hub staff participants the data will be very location-specific and generalisation to other settings will not be pursued.

Inclusion and exclusion criteria
All GPs employed at HMG will be encouraged to engage with the practice improvement concepts referred to in this project. All qualification levels will be permitted (i.e. interns, registrars, Fellows of the Royal Australian College of General Practitioners). GPs will prospectively identify patients who may benefit from a social activity. Current factors that may trigger a referral could include: living alone, socially or geographically isolated, low health literacy, recent admission to hospital, chronic medical conditions. All adult patients who have been referred to a community hub will be eligible to participate in the study and provided a study pack (information sheet, consent form, survey, referral to hub). Patients will not be referred to a community hub if the GP deems them unsuitable. Patients who cannot complete the self-assessment requirements alone will be offered support (e.g. survey questions being read aloud for those with low literacy; interpreter service where English is not the preferred language).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
unwillingness to participate (GP, patient, community hub)
patients deemed unsuitable by GP
patients unable to complete survey even with assistance from research team

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and statistical or power issues
Based on previous interest (Judi Walker et al., unpublished) it would be reasonably expected that the majority of the 16 GPs would provide an assessment of their baseline perception of SP and again at the end of the study period. Based on the work of Weiner et al., appropriateness and feasibility will be measured using the Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) respectively. These are two measures consisting of four questions each47. The number of patients to determine if the method of referral and engagement was acceptable will not be large. Numbers are likely to be limited by GP persistence with providing referrals, patient acceptance/consent and successful meetings with the community hub. Patients will provide a self-rated measure of social connectedness and health literacy at baseline (i.e. at entry into the study) and again at the end of the study period. Social connectedness will measured by the 6-item abbreviated version of the Lubben Social Network Scale (LSNS-6)48. An abbreviated form of the Health Literacy Questionnaire (HLQ) will be used to measure health literacy. All numerical data will be analysed using the paired Student’s t-test49,50. Analysis will be performed with the SPSS statistical package. If the change in scores are thought to be non-parametric, then the Wilcoxon signed rank sum test will be employed. Changes in magnitude may limit the usability of such analysis, in which case only non-generalisable comment will be made.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/09/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
28/03/2022
Actual
Sample size
Target
50
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 36314 0
7109 - Huonville
Recruitment postcode(s) [2] 36315 0
7112 - Cygnet
Recruitment postcode(s) [3] 36316 0
7113 - Franklin
Recruitment postcode(s) [4] 36317 0
7116 - Geeveston
Recruitment postcode(s) [5] 36318 0
7117 - Dover
Recruitment postcode(s) [6] 36319 0
7150 - Pelverata

Funding & Sponsors
Funding source category [1] 310462 0
Other Collaborative groups
Name [1] 310462 0
Primary Health Tasmania
Country [1] 310462 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Huon Valley Health Centre (now Huon Medical Group)
Address
85 Main Rd, Huonville TAS 7109
Country
Australia
Secondary sponsor category [1] 311611 0
University
Name [1] 311611 0
University of Tasmania
Address [1] 311611 0
Churchill Ave, Hobart TAS 7005
Country [1] 311611 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310093 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 310093 0
Ethics committee country [1] 310093 0
Australia
Date submitted for ethics approval [1] 310093 0
Approval date [1] 310093 0
30/07/2021
Ethics approval number [1] 310093 0
24892

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116442 0
Prof Gregory M Peterson
Address 116442 0
University of Tasmania
Churchill Ave, Hobart TAS 7005
Country 116442 0
Australia
Phone 116442 0
+61 3 6226 2197
Fax 116442 0
Email 116442 0
[email protected]
Contact person for public queries
Name 116443 0
Andrew Ridge
Address 116443 0
Huon Medical Group
85 Main Rd, Huonville TAS 7109
Country 116443 0
Australia
Phone 116443 0
+61 3 6264 2800
Fax 116443 0
Email 116443 0
[email protected]
Contact person for scientific queries
Name 116444 0
Gregory M Peterson
Address 116444 0
University of Tasmania
Churchill Ave, Hobart TAS 7005
Country 116444 0
Australia
Phone 116444 0
+61 3 6226 2197
Fax 116444 0
Email 116444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Numerical data will be collated and analysed as a whole. It will not be available publicly line-by-line to retain anonymity.
Qualitative data will be analysed thematically and not presented as individual patient data points


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.